3D Breast Ultrasound

SAN FRANCISCO – Jan 14, 2026 – iSono Health, a pioneer in AI-driven medical imaging, today announced the official commercial launch of ATUSA, the world’s first FDA-cleared, wearable, and fully automated 3D quantitative breast ultrasound platform.

The launch marks a significant shift in women’s healthcare, aimed at eliminating the long-standing bottlenecks of manual ultrasound, such as high operator dependency and limited access to specialized sonographers.

Unlike traditional handheld ultrasound systems that require a highly skilled technician to maneuver a probe, the ATUSA system utilizes a unique, hands-free wearable accessory. This design allows for a complete, standardized 3D scan of the entire breast volume in approximately two minutes—roughly 10 times faster than conventional manual methods.

"ATUSA is a system-wide upgrade for women's breast health," said Neda Razavi, CEO of iSono Health. "We are putting the power of a world-class radiology suite into the hands of local clinicians, replacing slow, manual workflows with real-time diagnostic images at the point of care."

Key Features and Clinical Impact

Operator Independence: The automated hardware ensures consistent, high-fidelity 3D volumes regardless of the user’s clinical background, making it ideal for OB/GYN and primary care offices.

Advanced AI Integration: The platform is designed to work with "Sentient" AI models that utilize acoustic biomarkers and machine learning to provide real-time diagnostic support.

Dense Breast Screening: The technology is particularly vital for women with dense breast tissue, where traditional mammography may have limited sensitivity.

The AUDIBLE Study: Validating the Future AUDIBLE ： Coinciding with the commercial launch, iSono Health has initiated the AUDIBLE Study, a pivotal multicenter clinical trial supported by the National Institutes of Health (NIH). This 800-patient study will evaluate the diagnostic performance of the ATUSA platform against established imaging modalities, including traditional mammography and MRI.

Market Momentum As part of its expansion, iSono Health has opened its Series A financing during JPMorgan Healthcare Week to accelerate global deployments. The company has already begun onboarding clinics through its Pioneering Partner Program, signaling a new era where high-quality breast imaging is as accessible as a routine check-up.